(29 days)
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No
The description focuses on the material properties and curing mechanism of a dental composite, with no mention of AI or ML.
No
The device description indicates it is a dental composite material used for restorative purposes (filling cavities), not for treating a disease or condition.
No
This device is a dental composite material used for restorative purposes, specifically for filling cavities. It does not perform any diagnostic functions.
No
The device description clearly indicates BISFIL 2B is a physical composite material used in dental procedures, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "base increment posterior composite" for dental restorations. This is a material used in the body (or on the body, in the case of teeth), not for testing samples from the body.
- Device Description: The description details its use in a dental procedure ("directed shrinkage posterior composite technique") and its interaction with tooth structure (dentin, enamel). This further confirms its application within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a restorative material used directly in the mouth.
N/A
Intended Use / Indications for Use
BISFIL 2B is indicated for use as a base increment posterior composite. It is intended to be used with ALL-BOND 2ª or ONE-STEP", or similar universal dental adhesive system. BISFIL 2B will bond to the enamel / dentin bonding system such as ONE-STEP. BISFIL 2B is intended to be covered by a high quality light-cure composite.
Product codes
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Device Description
BISFIL 2B (directed shrinkage composite) is a self-cure, base increment, radiopaque composite recommended for the "directed shrinkage" posterior composite technique suggested by Dr. Raymond Bertolotti.
BISFIL 2B begins curing adjacent to the naturally warmer surfaces of the dentin in the directed shrinkage technique. This is in contrast to light-cure composites which tend to begin curing towards the light source. Since all composites shrink on curing, the net effect of the directed shrinkage technique is to direct polymerization toward the tooth to help prevent formation of a marginal gap.
BISFIL 2B is a naturally sticky, syringable composite that is intended to be overlaid with a condensable light-cure posterior composite such as AELITEFIL™ or BISFIL P". BISFIL 2B is intended to be used with ALL-BOND 2% or ONE-STEP", or similar universal dental adhesive system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association #27. Diametral tensile testing is an accepted method to characterize the tensile strength of relatively brittle materials and the flexural modulus has become important recently in characterizing the strength in three point loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BISFIL™ II
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Ka64000
BISCO, INC., 1500 W. Thorndate Ave., Itasca, IL 60143 510(k) submission for BISFIL™ 2B
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510(k) SUMMARY
As Required by the Safe Medical Devices Act of 1990
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
PREDICATE DEVICE
BISFIL™ II
BISFIL II is a self-cured, highly filled, radiopaque composite recommended for posterior restorations. The high filler concentration in BISFIL II (80%) results in improved abrasion resistance as well as high tensile and compressive strength. These are essential for composites to function effectively in the posterior properties segments. Optimum results require that BISFIL II be used in conjunction with a high quality dentin-enamel adhesive system such as ALL-BOND® 2 or ONE-STEP™
Leading clinicians (Dr. John Kanca, Middlebury, CT) have recommend that BISFIL II be used as the base increment, to replace dentin, underneath a light - cure restorative in the "directed shrinkage" technique. Being self - cured, BISFIL II tends to cure towards the warmth of the tooth, rather than towards a light source, to prevent development of a marginal gap.
DESCRIPTION OF THE APPLICANT COMPOSITE
BISFIL 2B (directed shrinkage composite) is a self-cure, base increment, radiopaque composite recommended for the "directed shrinkage" posterior composite technique suggested by Dr. Raymond Bertolotti.
BISFIL 2B begins curing adjacent to the naturally warmer surfaces of the dentin in the directed shrinkage technique. This is in contrast to light-cure composites which tend to begin curing towards the light source. Since all composites shrink on curing, the net effect of the directed shrinkage technique is to direct polymerization toward the tooth to help prevent formation of a marginal gap.
BISFIL 2B is a naturally sticky, syringable composite that is intended to be overlaid with a condensable light-cure posterior composite such as AELITEFIL™ or BISFIL P". BISFIL 2B is intended to be used with ALL-BOND 2% or ONE-STEP", or similar universal dental adhesive system.
INTENDED USES OF APPLICANT COMPOSITE
BISFIL 2B is indicated for use as a base increment posterior composite. It is
intended to be used with ALL-BOND 2ª or ONE-STEP", or similar universal dental adhesive system. BISFIL 2B will bond to the enamel / dentin bonding system such as ONE-STEP. BISFIL 2B is intended to be covered by a high quality light-cure composite.
1
CONCEPTS SIGNIFICANT PERFORMANCE SCIENTIFIC and CHARACTERISTICS
There has been a great deal of discussion in the dental research literature over the effect of polymerization shrinkage on the quality of a dental restoration. On the one hand, older systems did not bond to tooth structure so shrinkage simply resulted in gap formation between the tooth and restoration resulting in leakage and recurrent caries. Modern materials, on the other hand, bond well to tooth structure. During shrinkage, pain may occur due to stress placed on the tooth, a cusp may actually fracture because of the stress, or the bond may break resulting in leakage.
In the absence of a true non-shrinking composite, several tricks have been used to reduce or overcome the effects of polymerization shrinkage. One of these is the "directed shrinkage technique" propose by Dr. Raymond Bertolotti (see references). Bertolotti proposed that a self-cure composite will produce less shrinkage stress because, during curing, the stress is relaxed in the presence of uncured material. As the material cures more of the paste is converted to solid until such time as no fluid phase is present to accommodate the shrinkage, at which time the stress accumulates quickly. Conversely, a light-cure composite cures very quickly and there is very little time for the paste to accommodate shrinkage.
BISFIL 2B overcomes the above problems because of its higher resin content and its ability to flow while in the paste/fluid state during the early stages of curing. In addition. Dr. Bertolotti hypothesized that the warmer surface of the tooth will tend to polymerize the material in contact with it. This effectively causes shrinkage to occur toward rather that away from the tooth as might occur with a light-cure material. This hypothesis has been tested by Garberoglio (see References, #7) and others and found plausible.
The chemical composition of BISFIL 2B and BISFIL II are very similar. Both are silica and glass filled dimethacrylate composites. The resin compositions of both products are nearly identical with BISFIL 2B having somewhat less filler and lower viscosity.
The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association #27. Diametral tensile testing is an accepted method to characterize the tensile strength of relatively brittle materials and the flexural modulus has become important recently in characterizing the strength in three point loading.
Sam L. Sandik
James L. Sandrik, PhD BISCO, INC. Itasca, IL 60143
October 4, 1996